Alembic Pharmaceuticals Limited
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- India
- Registered address
- Formulation Division III, Plot No. 779P/790P, Village - Karakhadi, Taluka - Padra, Vadodara, Gujarat 391450, India (IND)
- Operations here
- manufacture
- FDA identifiers
- FEI 3015685305 · DUNS 675480734
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2026-02-18
- VAIDrug Quality Assurance2023-03-24
Drugs this plant is listed as making
29 distinct drugs across 60 products name this site in their FDA label.
- azelastine hydrochlorideAlembic Pharmaceuticals Limited
- Azelastine Hydrochloride Ophthalmic Solution 0.05%Alembic Pharmaceuticals Inc.
- Bepotastine Besilate Ophthalmic Solution 1.5%Alembic Pharmaceuticals Limited
- bimatoprostAlembic Pharmaceuticals Inc.
- Brimonidine TartrateAlembic Pharmaceuticals Inc.
- Brimonidine Tartrate and Timolol MaleateAlembic Pharmaceuticals Limited
- Brimonidine Tartrate ophthalmic solution, 0.15%Alembic Pharmaceuticals Inc.
- bromfenacAlembic Pharmaceuticals Limited
- Bromfenac Ophthalmic Solution 0.09%Alembic Pharmaceuticals Inc.
- Bromfenac SodiumAlembic Pharmaceuticals Limited
- Carboprost TromethamineAlembic Pharmaceuticals Limited
- DiazepamAlembic Pharmaceuticals Limited
- Dorzolamide HydrochlorideAlembic Pharmaceuticals Limited
- Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic SolutionAlembic Pharmaceuticals Inc.
- FulvestrantBluePoint Laboratories.
- GlycopyrrolateAlembic Pharmaceuticals Inc.
- IcatibantAlembic Pharmaceuticals Limited
- Ketorolac Tromethaminein shortageAlembic Pharmaceuticals Inc.
- Loteprednol etabonate and TobramycinAlembic Pharmaceuticals Limited
- Moxifloxacin ophthalmic solutionAlembic Pharmaceuticals Limited
- pantoprazole sodium injectionAlembic Pharmaceuticals Limited
- PhytonadioneAlembic Pharmaceuticals Limited
- sumatriptan succinateAlembic Pharmaceuticals Limited
- Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%Alembic Pharmaceuticals Inc.
- Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%Alembic Pharmaceuticals Limited
- Tobramycin Ophthalmic SolutionAlembic Pharmaceuticals Limited
- Travoprost ophthalmicAlembic Pharmaceuticals Inc.
- Triamcinolone AcetonideAlembic Pharmaceuticals Inc.
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.